Kornimate/medical-research-clean huggingface dataset:
assessment of potential interactions between cocaine and tolcapone - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess the potential interactions between intravenous (iv) cocaine and tolcapone.

double-blind, inpatient study by screening responses to cocaine infusions of 20 and 40 mg i.v. subjects into 1 of 2 treatment groups to assess potential interactions between i.v. cocaine infusion and treatment with tolcapone.

Eligibility criteria:
inclusion criteria: volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; dsm-4 criteria for cocaine abuse or dependence exclusion criteria: additional criteria available during screening at the site
substitution of sulfonylureas with new generation of hypoglycemic drugs for the treatment of type 2 diabetes mellitus

Conditions: T2DM (Type 2 Diabetes Mellitus); Diet, Healthy; Renal Function Disorder; Albuminuria

Summary: this is a multicentric, prospective, parallel groups study. patient recruitment will be carried out at the u.o. departmental endocrinology and diabetology asst fbf sacco, fatebenefratelli and ophthalmic hospital, and at the ssd of endocrine diseases and diabetology asst fbf sacco, l. sacco hospital. at the screening visit, patients being treated with sulfonylureas / glinids will be shifted, depending on the subject's biochemical and phenotypic characteristics, based on current prescribing criteria and diabetes complications, to one of 4 different types of treatment: 1. group 1: sglt2 inhibitors +/- metformin 2. group 2: dpp4 inhibitors +/- metformin 3. group 3: glp1-ra + long-acting insulin +/- metformin 4. group 4: sglt2 inhibitors + dpp4 inhibitors +/- metformin at the screening visit the clinician will evaluate which new treatment to assign to the patient, based on the subject's biochemical and phenotypic characteristics, current prescribing criteria and existing complications (algorithm for the treatment of diabetes mellitus, sid-amd care standard 2018)

approximately 500 t2dm patients aged ≥18 years will be enrolled according to the guidelines of the american diabetes association (ada) with poor glycemic control (hemoglobin a1c \[a1c\] ≥6.5% and ≤11% \[≥58 mmol / mol and ≤97 mmol / mol\]), in stabilized treatment with sulfonylureas / glinids, which meet all the study enrollment criteria. during the study 7 visits are scheduled which coincide with the routine diabetic visits. during the scheduled visits the patients of the study will be subjected to: * enrollment on the first visit if the inclusion criteria are met and those of exclusion are absent * anamnestic and clinical collection * evaluation of the type of treatment to which they have been assigned and possible modification of drug therapy in the in case that the desired glycemic target has not yet been reached up.

Eligibility criteria:
inclusion criteria: * age over 18 years; * 6.5% \<hba1c \<11%; * diagnosis of type 2 diabetes mellitus; * active treatment with sulfonylureas / glinids, both in monotherapy and in association with other long-acting hypoglycemic / insulins. * written informed consent of the patient or a legal guardian signed and dated exclusion criteria: * patients suffering from severe systemic diseases, fever, known chronic inflammatory states * pcr determinants\> 10 mg/l; * hba1c\> 11% or hba1c \<6.5%; * use of corticosteroids at the time of enrollment; * poor patient understanding of spoken and written italian; * absent compliance.

Keywords: sulfaniluree/glinidi
pain management in response to exparel vs. standard bupivicaine

Conditions: Pain

Summary: this study is looking to evaluate the efficacy of liposomal bupivicaine (exparel) on decreasing the amount of consumed pain medications. patients will be randomly selected to received either exparel or standard bupivicaine injection during surgery. patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.

exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection. it is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine. patients in group a will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (exparel) (266 mg, 20 ml, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space. patients in group b will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.

Eligibility criteria:
inclusion criteria: * all patients over 18 years of age * isolated thoracoscopic procedure for therapeutic or diagnostic purposes exclusion criteria: * previous ipsilateral thoracic surgery * need for operative pleurectomy or pleurodesis * chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (nsaids), sedatives, or hypnotics * allergies to bupivacaine or other local anesthetics, narcotics, nsaids or acetaminophen * liver dysfunction (inr \> 1.5, albumin \ 2mg/dl) * renal dysfunction (egfr \< 60ml/min/1.73m2) * history of peptic ulcerative disease * severe chronic obstructive pulmonary disease (copd) requiring continuous oxygen supplementation * inability to consent * pregnancy * need for conversion from a video-assisted thoracic surgery procedure to a thoracotomy * patient is discharged from the hospital with a chest tube in place * patient fails to comply with post-operative instructions

Keywords: exparel thoracoscopy bupivicaine liposomal
effect of atmospheric pollution on obstructive lung diseases

Conditions: Lung Diseases, Obstructive

Summary: several studies have demonstrated the association between atmospheric pollution and chronic respiratory diseases. the magnitude of this association and its dependence of local factors are still unknown in argentina, particularly for obstructive lung diseases like asthma and chronic obstructive pulmonary disease (copd). the objective of this study is to assess the effect of atmospheric pollution due to particulate matter (pm) on asthma and copd exacerbations in adults. a prospective cohort study will be carried out in patients attending the pulmonary service of a public hospital located in san nicolas, buenos aires province, argentina. patients will be followed for 12 months after recruitment. the outcome variables will be the frequency of hospitalizations or emergency department consults for asthma or copd exacerbations and related conditions, and the impact of copd on a person's life as measured by the copd assessment test (cat) questionnaire. the exposure will be the pollution level in the particular address, measuring pm10 concentrations with portable equipment. other variables as air temperature, humidity, and individual patient risk factors will be considered as potential confounders or effect modifiers. the associations will be estimated through regression models, i.e. logistic and poisson regressions and recurrent event survival analysis. the results of this study should provide elements to estimate the risk of chronic respiratory diseases associated with atmospheric pollution, and to evaluate strategies for risk assessment in the local community.


Eligibility criteria:
inclusion criteria: * patients with asthma or copd attending the pulmonary service. exclusion criteria: * patients who refuse to participate in this study or to sign the informed consent document.

Keywords: lung diseases, obstructive air pollution particulate matter
malt-derived ingredients and their prolactinotrophic effects

Conditions: Acute Response to Food Ingredient Consumption

Summary: this proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.


Eligibility criteria:
inclusion criteria: * subjects who have/are 1. willing and able to provide written informed consent 2. healthy women aged 18 to 40. 3. bmi in the range of 18 to 30. 4. willing to undergo an experiment in the follicular phase of the menstrual cycle i.e. day 0 to 14 of the menstrual cycle starting from the first day of the period. exclusion criteria: * subjects who have/are * allergic to tested products * under regular medication including oral contraceptive pills or other form of hormonal replacement therapy. * under medications which affects prolactin levels. * pregnant or lactating or planning to conceive during the study period. * smokers, or excessive alcohol consumption (alcohol intake higher than 2 servings per day. a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer) or other substance abuse. * not willing and/or not able to comply with the study procedures and requirements. * suffering from pre-existing medical conditions and chronic illnesses that in the opinion of the investigator may interfere with the study. * family or hierarchical relationships with research team members
isotretinoin plus dexamethasone in treating patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma. purpose: phase ii trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.

objectives: i. determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. ii. determine the toxicity of this regimen in these patients. iii. correlate the changes in serum interleukin (il)-6, il-6r, and c-reactive and il-6r expression on plasma cells in the bone marrow with response in patients treated with this regimen. outline: patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total. projected accrual: a total of 18-36 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: histologically confirmed multiple myeloma elevated monoclonal protein in serum and/or urine patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3\* platelet count at least 75,000/mm3\* \*unless secondary to multiple myeloma involvement of the bone marrow hepatic: bilirubin less than 1.5 mg/dl transaminase less than 2 times normal renal: creatinine less than 2.0 mg/dl no overt renal insufficiency cardiovascular: no congestive heart failure no myocardial infarction within the past 6 months no significant arrhythmia or poorly controlled hypertension pulmonary: no severe pulmonary disease other: triglycerides normal no other severe medical illness no active peptic ulcer disease no brittle insulin-dependent diabetes no severe depression or other psychiatric illness no active infection no history of severe ethanol or drug abuse not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: prior palliative radiotherapy allowed surgery: at least 3 weeks since prior major surgery

Keywords: stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
a study to evaluate the efficacy and safety of apremilast (cc-10004) in the treatment of behçet disease

Conditions: Behcet Syndrome

Summary: the purpose of this study is to assess whether apremilast is safe and effective in the treatment of patients with behcet disease.


Eligibility criteria:
inclusion criteria: * diagnosis of behçet disease. at the time of diagnosis, subjects must meet the international study group criteria for behçet disease * females of childbearing potential (fcbp) must have negative pregnancy tests and agree to use two forms of contraception throughout the study. * males must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with fcbp * laboratory criteria: hgb ≥ 9 g/dl, wbc count ≥ 3000 /microl and ≤14,000/microl, platelet count ≥ 100,000 /microl,, serum creatinine ≤ 1.5 mg/dl (≤ 132.6 μmol/l), total bilirubin ≤ 2.0 mg/dl, ast and alt ≤ 1.5 x uln * two or more oral ulcers over the 28 day period before screening, with or without current treatment * two or more oral ulcers at the time of randomization (visit 2, baseline) exclusion criteria: * pregnant or breast feeding * any condition which places the subject at risk * systemic fungal infection * history of tb infection within 3 years * history of recurrent bacterial infection * mycobacterium tb as indicated by a positive ppd skin test * history of incompletely treated mycobacterium tuberculosis * clinically significant chest x-ray abnormality at screening. * clinically significant ecg abnormality at screening * history of hiv infection * history of congenital or acquired immunodeficiency * hepatitis b surface antigen positive or hepatitis b core antibody positive at screening * antibodies to hepatitis c at screening * history of malignancy (except for treated basal-cell skin carcinomas \> 3 years prior to screening) * any active major organ involvement of behçet disease * use of concomitant immune modulating therapy or topical corticosteroids. * use of ocular corticosteroids * use of any investigational medication within 4 weeks prior to randomization or 5 pk/pd half-lives (whichever is longer)
effect of crestor (rosuvastatin) on lipid levels in patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (low density lipoprotein (ldl), high-density lipoprotein (hdl), total cholesterol, triglyceride) in patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * metabolic syndrome (according to national cholesterol education program (ncep) adenosine triphosphate (atp) ill criteria) * ldl-cholesterol \> 130mg/dl * hdl-cholesterol \< 40mg/dl in males and \<50mg/dl in females * triglycerides \< 400 mg/dl exclusion criteria: * with a concomitant coronary disease * currently under statin therapy or previously treated with statins within the last 6 months

Keywords: plasma lipid profile metabolic syndrome
automated screen for fetal aneuploidy

Conditions: Trisomy 21 and Other Fetal Aneuploidy

Summary: the purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old and can provide informed consent; 2. subject has a viable singleton or twin pregnancy; 3. subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw; 4. subject is planning to undergo chorionic villus sampling and/or amniocentesis for the purpose of genetic analysis of the fetus because of a suspected fetal chromosomal anomaly based on cell-free dna test results, standard serum screening result, or fetal ultrasound abnormality. 5. or the subject has already undergone chorionic villus sampling and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis. exclusion criteria: 1. subject (the mother) has known aneuploidy; 2. subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy; 3. subject has a fetal demise (including natural or elective reduction) identified prior to consent; 4. subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.

Keywords: fetal screening test trisomy aneuploidy copy number variant
inflammatory bowel disease in south eastern norway

Conditions: Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Disease

Summary: the ibsen iii study will investigate the incidence of inflammatory bowel disease in south eastern norway and describe the clinical course of the disease. the investigators will map newly diagnosed and treatment naive ibd patients at various levels (epidemiological, clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and microbial) as a basis to improve targeted and individualized treatment and care. the investigators will include incident ibd patients at all local- and university hospitals in the south eastern health region in 2016-2018 and follow-up prospectively for five years. the investigators will use standardized and validated registration methods allowing comparability with previous national and international ibd cohorts, link data to national health registries and collect blood, feces and biopsies for bio banking.


Eligibility criteria:
inclusion criteria: ulcerative colitis: diagnostic criteria (at least three out of four criteria present): 1. a history of diarrhea and/or pus in stools for more than 4weeks or repeated episodes. 2. macroscopic appearance at endoscopy of continuous mucosal inflammation affecting the rectum in continuity with some or the entire colon. 3. microscopic features on biopsy compatible with uc, 4. no suspicion of cd on small bowel x-ray, ileocolonoscopy or biopsy. crohn's disease: diagnostic criteria (at least two of four criteria present): 1. history of abdominal pain, weight loss and/or diarrhea for more than three months. 2. characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulceration) or cobble stoning or radiological features of stricture or cobble stoning. 3. histopathology consistent with crohn's disease (epitheloid granuloma of langerhans type or transmural discontinuous focal or patchy inflammation). 4. fistula and/or abscess in relation to affected bowel segments. inflammatory bowel disease, type unclassified (ibdu) : patients with evidence on clinical and endoscopic grounds for chronic inflammatory bowel disease affecting the colon, without small bowel involvement, and no definitive histological or other evidence to favor either cd or uc. pediatric patients: will be diagnosed according to the porto-criteria and defined as: pediatric onset ibd ≤ 16 years early onset ibd (eoibd) \< 10 years very early onset ibd (veoibd) \< 6 years infantile (and toddler) ibd \< 2 years neonatal ibd \< 28 days exclusion criteria: * other causes of acute or chronic bowel inflammation must be excluded, i.e. infectious colitis, radiation colitis, diversion colitis, solitary rectal ulcer syndrome, graft versus host disease, diverticular colitis, medication associated colitis, ischemic colitis, microscopic colitis, enema associated colitis. * refusal or not able to give informed consent

Keywords: uc cd ibd
retrospective study of the linear™ hip

Conditions: Osteoarthritis; Rheumatoid Arthritis; Femoral Fracture; Correction of a Functional Deformity; Avascular Necrosis

Summary: the purpose of this study is to evaluate the use and efficacy of the encore linear™ hip system in a group of 200 patients for whom data has already been collected.


Eligibility criteria:
inclusion criteria: * have hip joint disease related to one or more of the following * osteoarthritis * rheumatoid arthritis * femoral fracture * correction of a functional deformity * avascular necrosis of the natural femoral head * skeletal maturity * patient is likely to be available for evaluation for the duration of the study * able and willing to sign the informed consent and follow study procedures * patient is not pregnant * no infection present * no known materials sensitivity * patient is over 18 years of age exclusion criteria: * skeletal immaturity * infection or sepsis * insufficient bone quality that may affect the stability of the implant * muscular, neurologic or vascular deficiencies which compromise the affected extremity * alcoholism or other addictions * prisoners * high levels of physical activity * patient is pregnant * loss of ligamentous structures * materials sensitivity * patient is under 18 years of age
compuls-bed-severity

Conditions: Binge-Eating Disorder

Summary: * binge eating disorder (bed) has been fairly recently introduced into the diagnostic and statistical manual 5 psychiatric classification and its severity criteria are still not well established. * moreover, it remains unclear whether bed is associated with greater metabolic severity or more somatic comorbidities, especially in obesity. * improved bed severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care. the investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of bed (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated).


Eligibility criteria:
inclusion criteria: * men or women aged 1 * participants eligible for bariatric surgery (bmi\>40, or bmi\>35 with severe comorbidities) * participants scheduled for medical evaluation and treatment of obesity at the iucpq obesity clinic (bmi≥30) * participants scheduled for evaluation and treatment of bed at the cepia with obesity (bmi≥30) * for the group with bed: positive beds-7 screen and binge eating scale score \>16; * for the control group: have a negative beds-7 screen and binge eating scale score\<12 * be fluent in french and able to consent. exclusion criteria : * participants with severe neurological disorder and/or major neurocognitive deficits; * participants with previous bariatric surgery or with introduction or change of anti-obesity medication (liraglutide or naltrexone/bupropion) in the previous 3 months; * participants who cannot read and/or understand french; * participants under guardianship or curatorship; * participants already included in a study with a conflict of interest with this study; * inability to use a computer or ipad; * inability to access an internet connection or to visit one of the inclusion sites. secondary exclusion criteria: * participants with a discordance between beds-7 (positive) and binge eating scale (score ≤ 16) results found secondarily * participants who did not participate in part of the assessments (e.g., self-questionnaires or neurocognitive tests) and participants with a rate of missing data\>10%.

Keywords: binge-eating disorder impulsivity obesity attention emotional regulation